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To: James Baker who wrote (305)12/31/1997 6:18:00 PM
From: James B. Barnes  Respond to of 569
 
I must confess I thought today would be a down day. In the short term, the market has a great way of showing each of us how much we know.

James



To: James Baker who wrote (305)1/1/1998 1:40:00 PM
From: John McCarthy  Read Replies (2) | Respond to of 569
 
James -

BMY sells a generic cancer drug called Paclitaxel
for use against Breast, Ovarian , and K.S. cancers.
They sell it under the trade name TAXOL.

TAXOL will do $1 billion in revenues ($800 mil. USA /
$200 mil. international) in 1997. It will climb
towards $2 billion in 1998.

In early 1997 the Taxol monopoly became threatened from
NPRO/IVX who had developed their own Paclitaxel drug
under the trade name Paxene. They tested it against
K.S. because K.S. was the smallest and least costly
of the 3 indications. Approval against any 1 indication
enables selling for all 3 indications i.e. $1 billion market.

In early 1997 the FDA became aware of this, and in the course
of 5 weeks - FROM A STANDING STOP - BMY filed with the FDA
to have TAXOL reviewed under the Orphan Drug Statutes AND
the FDA agreed to review their request. This was in June.
In August the FDA ruled that TAXOL ($1 bil. drug) was indeed
an ORPHAN DRUG.

Why would they do this?

Currently, there are 160 Active Taxol trials.
(Type TAXOL in the DRUG textbox )
cancernet.nci.nih.gov

On December 26th, while everybody was still huggin their kids
the FDA made 1 ruling that said (1) Hey, sure Paxene
works - why wouldn't it - its PACLITAXEL (2) but, we're
sorry, the law has us by the nuts, TAXOL is an Orphan
Drug so Paxene cannot be sold until the year 2004.

There are still 160 Taxol trials going on.

Orthovisc will be on the market by June 30 - or sooner.

Regards,

John